Lukas Biomedical boasts a great team of professional medical experts and biomedical researchers, dedicated to developing high-quality, high-efficiency cellular therapy technologies to help cancer patients regain their health and hope.
Unlike typical biotech companies, Lukas Biomedical utilizes memory T cells with immune memory and specificity. Through patented cell culture technology, we purify and activate the body's immune cells, enabling them to actively identify and attack cancer cells.
After being cultured using biotechnology, the patient's own immune cells can not only recognize and attack cancer cells but also survive in the body for over a year, with fewer side effects and lower drug resistance. This helps cancer patients maintain their quality of life during treatment while reducing the risk of recurrence.
QC Implementation
Establish a quality plan in accordance with GTP (Good Tissue Practice) requirements, and develop and maintain relevant standard operating procedures (SOPs) for critical steps in cell production to ensure that human cell products are free from infectious disease pathogens, remain uncontaminated during manufacturing, and are not compromised due to improper manufacturing, thereby maintaining the efficacy and integrity of human cell products.
Establish a quality audit procedure to conduct audits and create a management review process to regularly review and analyze all product deviations, identifying trends and recurring issues related to product deviations.
Implement environmental controls through appropriate temperature, humidity control, air filtration, and microbial monitoring to establish clean production areas. Set up a remote monitoring system to monitor temperature, humidity, and pressure differentials with upper and lower limit values, sending alerts when anomalies occur to notify personnel for corrective action, thus preventing potential negative impacts on the functionality and integrity of the product.
Divide facilities and areas into independent work zones and implement access control systems, specifying the flow of personnel, materials, air, waste, and product to avoid contamination between clean and dirty areas.
Ensure that equipment is regularly calibrated by external units or by Lujia Biomedical staff following standard operating procedures, to verify that instruments function properly and meet required specifications. To maintain and manage laboratory instruments, use a labeling system to indicate calibration status, maintain instrument history records, and monitor calibration schedules through an annual maintenance plan.
Establish an appropriate organizational structure and provide sufficient personnel, all of whom undergo internal and external training, as well as continuing education. Personnel should be aware of the potential consequences of improper performance of their duties and only perform tasks they are qualified to carry out.
To maintain the quality of cell products, perform safety testing, including endotoxin testing, mycoplasma testing, and sterility testing. The safety testing of cell products complies with the principles of ISO 17025, and procedures for receiving and managing these tests are established to ensure the biological safety and integrity of the materials.
Implement emergency response and corrective actions when work control procedures and related standard operating procedures are not followed, including re-auditing product defects, evaluating the effectiveness of corrective actions, tracking improvement results, immediate corrective measures, and long-term preventive measures to avoid recurrence.
Risk Management System
Conduct at least one quality audit per year. If necessary, perform special audits to ensure the effective implementation of the quality plan and establish and maintain a master record of quality audit results.
From December 26, 2023, to December 27, 2023, undergo an on-site inspection for the extension of GTP (Good Tissue Practice) certification for the cell preparation facility by the Ministry of Health and Welfare's Food and Drug Administration (FDA). The GTP certification extension agreement (Document No. 1131663380B) was obtained on April 19, 2024.
Hold one management review meeting per year and prepare a report to regularly review and analyze all product deviations.
Patents
In 2015, exclusive authorization for Lymphotec's immune cell therapy technology in Taiwan was obtained. In 2017, all cell therapy technologies were fully transferred to Taiwan.
